# K041780: New Brid

- Pathway: 510(k) (Traditional)
- Applicant: Medical Imaging Solutions, Inc.
- Decided: Aug 11, 2004 after 41 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K890348 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems, Philips Medical Systems North America, Inc. (1999) Summary page 2.
- K960575: Advantx LCV+, GE Medical Systems (1996) Summary page 2.
- K023178: Innova 4100, Ge Medical Systems, Inc. (2002) Summary page 2.

## Indications for use
The system is intended for use in cardiovascular x-ray imaging applications, including diagnostic and interventional procedures (such as PTCA, stent placement, atherectomies), pacemaker implantations, and electrophysiology. It may also be used for other imaging applications at the physician’s discretion.

Source page: https://510kreport.com/device/K041780
Methodology: https://510kreport.com/methodology